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Converting One to a Million Scale-up Process for
Nanotechnology Commercialization
Nanotechnology
Scale-up to
Commercialization
“One to a Million”
Process Steps in Commercialization Planning
2
Information Implementation
Production Equipment
Evaluation and Scale-up
Testing and Pilot
Governmental compliance
Toxicity and Product
EHS Testing
Product Life Cycle
Nano-PM Readiness
Survey Markets and
Product
Program Execution Planning
Understanding
Insurance
Finance
Government & Logistics
Nanotechnology
Scale-up to
Commercialization
“One to a Million”
Understanding Product Life Cycle
Define position within the Product Life Cycle
Each stage has Barrier Gate to the next level
Each Gate exponentially transforms complexity from Technical issues to Commercial
Time to Market is limited and may collapse
Market Entry Gate is most volatile and where the “Valley of Death” is most prominent
3
Nanotechnology
Scale-up to
Commercialization
“One to a Million”
Process Scale-up Nanotechnology researchers skill set quickly becomes tested as complexity expands outside the product into business and facilities.
Lab scale
Kilo Lab
Pilot Plant
Manufacturing plant
Cost
Time
Nano-PM provides needed expertise in material science, process expansion, regulatory compliance, facility scoping, budgeting, and schedules.
Nanotechnology
Scale-up to
Commercialization
“One to a Million”
Applications of the Nanomaterial
Identify End Products
Define Customers
Technical Competition, both nano and current technology.
Size of current market, market growth and useful life (obsolescence)
Unit Sale Price vs. Cost to Produce – current versus projected (estimated)
5
Market Potential • Short term
• Medium term
• Long term
Understanding Markets and Products
Nanotechnology
Scale-up to
Commercialization
“One to a Million”
Understanding Readiness to Proceed
Nano-PM
Readiness
Survey
6
Understanding:
• Position in Product Life Cycle
• Market and Product
• Readiness Scoring
Allows transition to next
step- Information Gathering
Nanotechnology
Scale-up to
Commercialization
“One to a Million”
Information Production Equipment - Lab to Plant
Scale-up of Equipment
• Full Equipment Set Defined
• Throughput and Reliability
• Costs and Options
7
Identify Grams to Tons Requirement
The “One to a Million”
Early Equipment Validation Trials
Nanotechnology
Scale-up to
Commercialization
“One to a Million”
Information Toxicity and EHS Testing
• Extensive product Testing
• Safety of Product during production
• Safety of Product for Use
• Long Term Impact on Health
• Impact on Environment
8
NanoTox
Nanotechnology
Scale-up to
Commercialization
“One to a Million”
Information Governmental Compliance
• Global Governmental Regulations
• International Standards for Nano
• Transportation Restrictions
• Evaluate ISO Standard 13121
9
Governmental Regulations
Nanotechnology
Scale-up to
Commercialization
“One to a Million”
Information Testing and Pilot
Pending Informational Issues found-
• Run Equipment Pilots for Scale-up with Equipment Vendors
• Mitigation methods test for EHS issues
• Trial runs of products
• Pilot test of governmental approval
• Test batch transport and logistics issues
10
Plan for Testing of Risks
Pilot Production
Nanotechnology
Scale-up to
Commercialization
“One to a Million”
Information Gathering Data for Informed Decisions
11
Information Gathering on:
• Production Equipment
• Toxicity and EHS
• Governmental Regulations
• Testing and Pilots
Allows transition to next step:
Implementation of a Clear Strategy and
Program Execution Plan
Nanotechnology
Scale-up to
Commercialization
“One to a Million”
Implementation developing a Program Execution Plan
Program Execution Plan Executive Summary Program Description Technology
Product Positioning
Life of product and obsolescence
Usage and commercial viability
Geographic positioning of market
Geographic optimization of manufacturing Phasing Plan and Schedules Financing, Budgets and Costing Organization and Resources Risks EHS Quality Administration and Governance Operations
12
Nanotechnology
Scale-up to
Commercialization
“One to a Million”
Implementation Insurers & Risk Management
Alignment of Risk Stakeholders
Information stage collected data focused on Insurer requirements Questionnaire for Readiness focuses on key
risk and insurance issues Product manufacturing EHS risks – captured by
NanoTox and toxicity testing Long term Liabilities focused on end products
Insurance Partners included in plan
Risk Management
Program Execution Planning
Captures all risk elements and how either insured or mitigated
13
Nanotechnology
Scale-up to
Commercialization
“One to a Million”
Implementation Incorporating Investors
14
Alignment of Financial Stakeholders
Information stage collected data focused on investor risk issues. Questionnaire for Readiness defines areas of
potential market revenue, costs, viability Information stage develops equipment cost,
detail capital needs, phasing of budgets Business Model and projections
Investment Partners included in plan
Banks, Venture Capital, Funding
Program Execution Planning
Captures financial model for budgets, cash flow, sources of funding, financial controls and governance
Nanotechnology
Scale-up to
Commercialization
“One to a Million”
Implementation Governments and Logistics
15
Alignment of External Stakeholders
Information stage collected data focused on external positive or negative influences. Questionnaire for Readiness outlines
geographic areas, governmental and community support and or regulations
Information stage develops detail of regulatory environment and risks to product development
Information stage outlines community, supplier, or customer support or resistance
Governmental issues and Logistics Providers included in plan
Program Execution Planning
Captures influence in various sections of Risk, Financing, Schedule restraints, etc.
Nanotechnology
Scale-up to
Commercialization
“One to a Million”
Checkpoint: Change and Flexibility in Planning
Technology and Innovation Fact:
Constant Change in Conditions-
Plans can be outdated immediately!
Establish:
Lessons Learned at each step
Change Management Know when you are changing Know when to stop changing Know when change is necessary
16
Nanotechnology
Scale-up to
Commercialization
“One to a Million”
Questions Process Steps for Commercialization
17
Following the Steps: • Understanding
• Information Gathering
• Implementation Planning
Allows small steps and clear investment of resources to get to the next level
Reduces risks in each step
Challenges Plans based on data
Includes Stakeholders in Final Plan
Nanotechnology
Scale-up to
Commercialization
“One to a Million”
Thank You!
Contact:
Nano-PM
Dan Bassett Colorado [email protected]
Bob Predmore Arizona [email protected]
Harry Bushong Texas [email protected]
18
Nanotechnology
Scale-up to
Commercialization
“One to a Million”
Backup Information
19
Nanotechnology
Scale-up to
Commercialization
“One to a Million”
Preliminary Business Risk Matrix
Technology
Review
Estimate (s)
Development
Risk Matrix &
Business Plan
Capital Cost Estimate
Life Cycle
Raw Materials
Engineering
Labor Study
Priced Equipment List
Materials Takeoff/ Pricing
Site General Conditions
Range Estimating
Estimate Reviews
Sales Price
Capacity Requirements
Net Present Worth
Depreciation
Internal Rate of Return
Working Capital
Value engineering (2)
PSM support
Debottlenecking Issues
Hazard analysis
SHE issues
Constructability (2)
Cost benefit analysis
Time to Market
Phasing Plans
ROI Analysis
Facility & Ops
Questionnaire
Production Equipment Layout plot plans
Major Manufacturing Equipment
Design Criteria
Life Safety Analysis
Specialized HVAC Systems
Building Architecture
Special Piping /Plumbing
Electrical
Controls
Security
Environmental
Materials of Construction
Kickoff
Submit Questionnaire
Strategic dates
Master project schedule Develop WBS
Production startup schedule
Team Coordination (Responsibility Matrix)
Owner supplied info
Location
Black box equipment info
Code studies/permits
SHE status
Product Validity
Site visits
Initial Funding
Status of Lab Studies
Rate Controlling Steps
Life Safety Analysis
Scale up Studies
Product Stability
Product Uniformity
Raw Material Quality
Process Modeling
Turndown Ratio
Nameplate Capacity
Number of Trains
Storage of Product
Storage of Raw Materials
Environmental
Design Criteria
Our proposed initial step is to conduct a questionnaire matrix to determine the Technical and Business readiness to assist new Nano scale-up planning
20
Nanotechnology
Scale-up to
Commercialization
“One to a Million”
21
Project Management Gate Process
1.0
Business
Planning
2.0
Concept Facility
Planning
3.0
Front End Design
4.0
Project
Execution
5.0
Operation &
Evaluation
Business Need
Project Sponsor
Steering Team
Project Charter
Sales Forecast
Sourcing Alternatives
Target Site
Technology Alternatives &
Assessments
Legal & Environmental
Concept Designs Options
Operate & Maintain
Milestone Schedule
ROM estimate (+/-50%)
ROI Analysis
Economic Evaluation of Alternatives
Final Site Selection
Conceptual Design Scope Including Flow Sheets
Preliminary Project Execution Plan
VAR–Value Added Record
Risk Analysis
Resource Commitments
Readiness Review
Master Schedule
Conceptual Estimate (+/-30%)
Project Design Basis
Project Execution Plan
Validation Master Plan
Long Lead Equipment Order Placement
Frozen Scope Document
Facility Acceptance Criteria
Risk Assessments
Project Review
Peer Review
3rd Party estimate Review
Project Baseline Schedule
CR Estimate (+/-10%)
1 2 3
Decision Gate Reject or
Recycle Approve
Decision Gate Reject or
Recycle Approve
Decision Gate Reject or
Recycle Approve
Initial Capital Request ► Supplemental request ► Full Funding Request ►
On completion of the Risk Matrix the focus will be to provide services for: Business(1.0) & Facility Plan (2.0) then Owner’s Representation for (3.0-5.0)
21
Stability Tests
Performance
Benchmark
Certification or Accreditation
Project Close-out
Share Lessons Learned
Identify Improvement Opportunities
Reject or
Recycle
Decision Gate
Approve
Turn over to Operations 4 5
Decision Gate Reject or
Recycle
Environmental / Construction Permits
Implement Project Controls to baselines
Execution Contract Awards
Completed Engineering Work Packages
Completed Construction & Equipment Install
Construction & Equipment
Start-Up and Commissioning
Owner Operations Move-In
Approve
Design / Build ►
MAJOR DELIVERABLES
Nanotechnology
Scale-up to
Commercialization
“One to a Million”
Owners Rep Scope of Project Services
Design
4.0 Construction
4.0
Operations &
Maintenance 5.0
Feasibility studies
Evaluation of alternatives
Conceptual cost estimating
Technology development
Technology scale-up
Process simplification
Project economic analysis
Site selection
Environmental assessments
PSM permitting–HAZOPS
Dynamic simulation analysis
Process engineering design
Detailed engineering
Equipment design
Facilities design
Instrumentation / Automation
Systems integration
CADD
Reliability analysis
Value engineering
Constructability reviews
Operability studies / manuals
Environmental and permitting assistance
Safety management
Planning and scheduling
Constructability
Labor relations/hiring
Community relations
Craft training
On-site materials management
Site security
Productivity management
Quality assurance
Field engineering
Prefabricate/Modularize
Mechanical integrity–PSM
Construction support facilities
Facility turnover/ commissioning
Plant operations
Maintenance/modifications
Facilities management
Operations training/start-up support
Predicative maintenance
PSM support
Contract maintenance
Warehouse management
Facility management
Debottlenecking
Safety programs/management
Asbestos/lead abatement
Non destructive testing
Shutdown/outage planning
Environmental assessment
Environmental permitting assistance
Asset retirement
Procurement
4.0
Global sourcing
Shop evaluations
Requisitioning/bid conditioning
Contracts negotiations
Vendor surveillance
Logistics
Expediting
Quality assurance
Vendor document control
Warranty/service management
Supply chain management
Front
End
3.0
Estimate
Master project schedule
Process flow diagrams
Utility summary
Utility flow diagrams
Waste handling requirements
Interlock classifications and descriptions
Instrument list
Piping requirements
Special fittings list
Building & site requirements
Equipment arrangements and plot plans
Power distribution plan
Area electrical classification
Process descriptions
Detailed process control descriptions
Process control hardware description
Control system functional description
Project Oversight is needed in the downstream execution steps as the Nanomaterial supplier & Nanomaterial purchaser move forward
22
Nanotechnology
Scale-up to
Commercialization
“One to a Million”
Risk Management Highlights Challenges
IDENTIFY • Risk-based
Questionna
ire
• Brainstorm
ing
• Experience
• Ad Hoc
Risks
QUANTIFY
Quantifies Risks:
• Relational analysis
• Probability of
Occurrence (RP)
• Impact of
Occurrence (RI)
Risk Exposure
Risk Exposure
is Low
STRATEGIZE
Risk Mitigation
Strategy
Monitors
Contingency
(RI)
(RP)
Risk Watch
List
Risk
Exposure
Is High or Moderate
Risk Database
Risk Has Been
Mitigated
Contract Master Schedule
MITIGATION
IPT Implements
Mitigation Strategy
Our Risk Management Process to Identify, Quantify, Strategize and Minimize Risks, starts early and is continuous along the entire project lifecycle
23
Nanotechnology
Scale-up to
Commercialization
“One to a Million”
24
drop down lists, please select other and place a short answer in the text
block provided.
1. Name of the Person Completing this Survey
(Provide two responses.)
2. Street Address
[ ]
3. Country or Region of Your Research or Business
(Select all that apply.)
[ ]Abu Dhabi
[ ]Albania
[ ]Andora
[ ]Argentina
32. 1.12.4 Uptime Factor - Identify potential causes of downtime and there frequency i.e. cleaning equipment, maintenance, etc
33. 1.12.5 Technology Alternatives - Define list of alternative technologies explored in the development process
34. 1.12.6 Identify Strategic Dates - Identify the key dates to get
product developed and to market
35. 1.13 Product Specifics - Define the chemical name, and chemical makeup of the product
36. 1.13.1 Product Stability - What is the product shelf life
37. 1.13.2 Product Sales Price - Define the estimated sales price in $/lb or similar currency
38. 1.13.3 Product Raw Materials Cost - Identify all known aspects of
current raw materials and their availability
285.
Sub Question: Raw Material #2 Select Unit of Weight Measure in
this window. It will then skip to where the quantity or actual weight should be entered.
( )grams (Skip to Q. 286)
( )kilograms (Skip to Q. 286)
( )ounce (Skip to Q. 286)
( )lbs (Skip to Q. 286)
( )tonne (Skip to Q. 286)
( )ton (us) (Skip to Q. 286)
286. Sub Question: Raw Material #2 According to Weight Measure
Selected in Prior Window
[ ]
287. If you plan on multiple product lines what Percentages of Production volume for each planned industrial function of the
Nanomaterial. Product Line #1
( )Product Line #1 (Skip to Q. 288)
288. Product Line #1 Percentage (Combined selections shall equal 100%)
[ ]
407.
Are procedures communicated to customers in order to inform
them on how to safely use, dispose of, or recycle the product and manage environmental, health, and safety risks?
( )Yes
( )No
( )Not Yet
( )Not Applicable
408.
Do labels and other safety-information communications indicate
the extent of harm that could result from reasonably foreseeable misuse?
( )Yes
( )No
( )Not Yet
( )Not Applicable
409.
Does packaging comply with transportation and risk
regulations? Are workers and customers throughout the lifecycle adequately informed and protected?
( )Yes
( )No
( )Not Yet
( )Not Applicable
410. Is the environment protected from the identified hazards?
( )Yes
( )No
( )Not Yet
( )Not Applicable
411. Are warnings (if applicable) available throughout the product
Nanotechnology
Scale-up to
Commercialization
“One to a Million”
25
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